Breast CancerI-SCREENNCT06177795
Increasing Screening for Cancer Using EHR-Nudges
A study testing Post-visit patient text messaging, Default pended order and High risk bidirectional post-visit text messaging in people with Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 2 sites in United States.
Trial summary
In this study, personalized nudges to clinicians and patients will be evaluated to help increase breast cancer screening rates in accordance with USPSTF guidelines among women with a primary care visit, with a particular emphasis on those at high risk for non-completion of cancer screening. Read more about this study
- Who is it for?
- Ages 40 to 74 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Post-visit patient text messaging, Default pended order and High risk bidirectional post-visit text messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21,123 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Dec 2023to 7 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must meet the following criteria to be eligible:
- Women between 40 and 74 years of age
- A scheduled new or return (non-urgent/sick) primary care visit at one of the study practices (Penn Trial) or with one of the study primary care providers (UH Trial)
- Are overdue and eligible for a mammogram per Health Maintenance
- Does not have a future scheduled mammogram appointment
- For the Penn Trial patient intensification nudge, at least one of the following criteria must be met to be considered high risk and randomized to receive the intensification nudge:
Show all 10Show fewer
- Medicare Insurance
- Medicaid Insurance
- No EHR patient portal account
- Zero log-ins to EHR patient portal in the previous year
Who cannot join
- Patients will be excluded from the study if:
- History of bilateral mastectomy
- Have a mammogram exclusion modifier in Health Maintenance
- Have no phone number (home or mobile) listed in their chart (Penn Trial only)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Case Western Reserve University/University Hospitals
Cleveland, Ohio, 44106
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
About this study
Official title: I-SCREEN: Increasing Screening for Cancer Using a Randomized Evaluation of EHR-based Nudges
In this study, personalized nudges to clinicians and patients will be evaluated to help increase breast cancer screening rates in accordance with USPSTF guidelines among women with a primary care visit, with a particular emphasis on those at high risk for non-completion of cancer screening. In partnership with Penn Medicine (Penn) and Case Western Reserve University-University Hospitals (UH), two complementary, concurrent, 6-month, cluster-randomized, pragmatic trials will be conducted. Those assigned to the intervention arm will receive the following clinician and patient level nudge interventions: clinicians will receive a default pended order for a mammogram in the visit encounter in the EHR (Penn and UH), and patients will receive post-visit text message reminders to encourage them to schedule their mammogram (Penn). Patients identified as high risk for noncompletion will be individually randomized to receive an additional bidirectional text message nudge or the standard text messaging (Penn).
Read the detailed description
Cancer is a leading cause of mortality in the United States. While strong USPSTF guideline recommendations support appropriate screening for early detection and to avoid preventable deaths, breast cancer screening is often underutilized. Increasing breast cancer screening rates is challenging, in part, because it requires complementary decisions from clinicians (e.g., recommend and counsel patients about screening) and patients (e.g., to internalize risks and choose to complete screening). Presently, the lack of interventions directly targeting both clinicians' and patients' decision-making may underscore the relatively stagnant screening rates in the United States. There is a significant need to develop and scale low-cost interventions that increase breast cancer screening while simultaneously addressing the needs of high-risk patients and reducing disparities. Building upon prior work, the investigators propose to develop and test EHR-based clinician and patient nudges, with an additional intensified nudge to high-risk patients, to help increase screening mammography rates.
This study consists of two complementary and concurrent, cluster-randomized, pragmatic trials to be conducted at Penn and UH.
- Conditions
- Breast Cancer
- Being tested
- Post-visit patient text messaging, Default pended order, High risk bidirectional post-visit text messaging
- Keywords
- Screening, Mammogram, Behavioral Economics, Prevention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-visit patient text messagingBehavioural
Patients will be sent text message reminders 4 days and 14 days after their primary care visit. The message delivered 4-days post-visit will remind the patient that a screening mammogram was recently ordered by their doctor, that appointments have been reserved for them, and to pre-commit to scheduling. The message delivered at 14-days post-visit will remind the patient of their recent screening mammogram order and encourage them to schedule their appointment, if one has not already been scheduled.
Default pended orderBehavioural
A default pended order for a mammogram will be pended to the patient's upcoming primary care encounter and will be visible to the provider during the visit encounter. Clinical staff will have the option of signing the order or dismissing it if they deem it inappropriate for a given patient.
High risk bidirectional post-visit text messagingBehavioural
High risk patients randomized to receive the high risk intensification nudge will receive a bidirectional text messaging component after their visit. This intervention will query the patient about common questions or concerns about breast cancer screening. The bi-directional text messaging intervention will provide additional educational materials based on patient response as well as information about resources to help navigate to screening.
| Study group | Role | What they receive |
|---|---|---|
| Penn: Control | No intervention | Clinics randomized to the control arm will receive standard of care. |
| Penn: Intervention | Experimental | Clinics randomized to the intervention arm will receive the toolkit of clinician and patient facing nudges. Patient nudges will be post-visit text message reminders (standard messaging content). Clinician nudges will be default pended orders. Receives: Behavioral: Post-visit patient text messaging; Behavioral: Default pended order |
| Penn: High Risk Intensification | Experimental | Patients in the intervention clinics identified as high risk for noncompletion of mammogram will be randomized 1:1 to receive the high risk intensification arm or remain in the standard intervention arm. Patients in the high risk intensification arm will receive an additional bidirectional texting component. Receives: Behavioral: Post-visit patient text messaging; Behavioral: Default pended order; Behavioral: High risk bidirectional post-visit text messaging |
| UH: Control | No intervention | Primary care providers randomized to the control arm will receive standard of care. |
| UH: Intervention | Experimental | Primary care providers randomized to the intervention arm will receive default pended orders for a mammogram. Receives: Behavioral: Default pended order |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Who Complete a Screening Mammogram Within 3 Months After the Visit
The primary outcome is screening mammogram completion within 3 months after the first eligible primary care visit.
Measured: 3 months
Secondary outcomes (1)
Proportion of Patients Who Complete a Screening Mammogram Within 6 Months After the Visit
The secondary outcome is screening mammogram completion within 6 months after the first eligible primary care visit.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start18 Dec 2023
- Primary completion7 Jan 2025
- Study completion7 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For the Penn trial, primary care clinics will be randomized 2:1 to the intervention arm or control arm using covariate-constrained randomization. Patients identified as at high-risk for non-completion of breast cancer screening will be additionally randomized 1:1 at the individual level to receive an additional intensification nudge compared with the multi-component nudge intervention alone. Penn Medicine is expected to enroll approximately 15,000 patients. For the UH trial, primary care providers will be randomized 1:1 to the intervention or control arm using covariate-constrained randomization. UH is expected to enroll approximately 6,416 patients.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 21,123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Case Western Reserve University
- Responsible party
- Principal investigator, Amol Navathe, Abramson Cancer Center at Penn Medicine
- Investigators
- Amol Navathe, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177795
- Sponsor's protocol ID
- UPCC 12022
- Other IDs
- R33AG068947
- Acronym
- I-SCREEN
- Status last verified
- Apr 2026
- First submitted
- 11 Dec 2023
- Last updated
- 6 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I-SCREEN: Increasing Screening for Cancer Using a Randomized Evaluation of EHR-based Nudges
- ClinicalTrials.gov ID
- NCT06177795
- Acronym / sponsor ID
- I-SCREEN / UPCC 12022
- Conditions
- Breast Cancer
- Keywords
- Screening, Mammogram, Behavioral Economics, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21,123 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Case Western Reserve University
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 7 Apr 2025 (actual)
- First posted
- 20 Dec 2023 (actual)
- Results
- Posted 6 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, personalized nudges to clinicians and patients will be evaluated to help increase breast cancer screening rates in accordance with USPSTF guidelines among women with a primary care visit, with a particular emphasis on those at high risk for non-completion of cancer screening. In partnership with Penn Medicine (Penn) and Case Western Reserve University-University Hospitals (UH), two complementary, concurrent, 6-month, cluster-randomized, pragmatic trials will be conducted. Those assigned to the intervention arm will receive the following clinician and patient level nudge interventions: clinicians will receive a default pended order for a mammogram in the visit encounter in the EHR (Penn and UH), and patients will receive post-visit text message reminders to encourage them to schedule their mammogram (Penn). Patients identified as high risk for noncompletion will be individually randomized to receive an additional bidirectional text message nudge or the standard text messaging (Penn).
Detailed description
Cancer is a leading cause of mortality in the United States. While strong USPSTF guideline recommendations support appropriate screening for early detection and to avoid preventable deaths, breast cancer screening is often underutilized. Increasing breast cancer screening rates is challenging, in part, because it requires complementary decisions from clinicians (e.g., recommend and counsel patients about screening) and patients (e.g., to internalize risks and choose to complete screening). Presently, the lack of interventions directly targeting both clinicians' and patients' decision-making may underscore the relatively stagnant screening rates in the United States. There is a significant need to develop and scale low-cost interventions that increase breast cancer screening while simultaneously addressing the needs of high-risk patients and reducing disparities. Building upon prior work, the investigators propose to develop and test EHR-based clinician and patient nudges, with an additional intensified nudge to high-risk patients, to help increase screening mammography rates.
This study consists of two complementary and concurrent, cluster-randomized, pragmatic trials to be conducted at Penn and UH.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- For the Penn trial, primary care clinics will be randomized 2:1 to the intervention arm or control arm using covariate-constrained randomization. Patients identified as at high-risk for non-completion of breast cancer screening will be additionally randomized 1:1 at the individual level to receive an additional intensification nudge compared with the multi-component nudge intervention alone. Penn Medicine is expected to enroll approximately 15,000 patients. For the UH trial, primary care providers will be randomized 1:1 to the intervention or control arm using covariate-constrained randomization. UH is expected to enroll approximately 6,416 patients.
| Arm | Type | Receives |
|---|---|---|
| Penn: Control | No intervention | –Clinics randomized to the control arm will receive standard of care. |
| Penn: Intervention | Experimental | Behavioral: Post-visit patient text messaging, Behavioral: Default pended orderClinics randomized to the intervention arm will receive the toolkit of clinician and patient facing nudges. Patient nudges will be post-visit text message reminders (standard messaging content). Clinician nudges will be default pended orders. |
| Penn: High Risk Intensification | Experimental | Behavioral: Post-visit patient text messaging, Behavioral: Default pended order, Behavioral: High risk bidirectional post-visit text messagingPatients in the intervention clinics identified as high risk for noncompletion of mammogram will be randomized 1:1 to receive the high risk intensification arm or remain in the standard intervention arm. Patients in the high risk intensification arm will receive an additional bidirectional texting component. |
| UH: Control | No intervention | –Primary care providers randomized to the control arm will receive standard of care. |
| UH: Intervention | Experimental | Behavioral: Default pended orderPrimary care providers randomized to the intervention arm will receive default pended orders for a mammogram. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Women between 40 and 74 years of age
- A scheduled new or return (non-urgent/sick) primary care visit at one of the study practices (Penn Trial) or with one of the study primary care providers (UH Trial)
- Are overdue and eligible for a mammogram per Health Maintenance
- Does not have a future scheduled mammogram appointment
- For the Penn Trial patient intensification nudge, at least one of the following criteria must be met to be considered high risk and randomized to receive the intensification nudge:
Key exclusion criteria (4 listed)
- History of bilateral mastectomy
- Have a mammogram exclusion modifier in Health Maintenance
- Have no phone number (home or mobile) listed in their chart (Penn Trial only)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post-visit patient text messagingPatients will be sent text message reminders 4 days and 14 days after their primary care visit. The message delivered 4-days post-visit will remind the patient that a screening mammogram was recently ordered by their doctor, that appointments have been reserved for them, and to pre-commit to scheduling. The message delivered at 14-days post-visit will remind the patient of their recent screening mammogram order and encourage them to schedule their appointment, if one has not already been scheduled. | Behavioural | Penn: High Risk Intensification, Penn: Intervention |
| Default pended orderA default pended order for a mammogram will be pended to the patient's upcoming primary care encounter and will be visible to the provider during the visit encounter. Clinical staff will have the option of signing the order or dismissing it if they deem it inappropriate for a given patient. | Behavioural | Penn: High Risk Intensification, Penn: Intervention, UH: Intervention |
| High risk bidirectional post-visit text messagingHigh risk patients randomized to receive the high risk intensification nudge will receive a bidirectional text messaging component after their visit. This intervention will query the patient about common questions or concerns about breast cancer screening. The bi-directional text messaging intervention will provide additional educational materials based on patient response as well as information about resources to help navigate to screening. | Behavioural | Penn: High Risk Intensification |
Primary outcome
Proportion of Patients Who Complete a Screening Mammogram Within 3 Months After the Visit
Time frame: 3 months
The primary outcome is screening mammogram completion within 3 months after the first eligible primary care visit.
1 secondary outcome
Proportion of Patients Who Complete a Screening Mammogram Within 6 Months After the Visit
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Breast Cancer
Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
RecruitingPhase 1/2
A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
Breast Cancer
Not yet recruiting
Podcast-Based Psychosocial Support for Women Newly Diagnosed With Breast Cancer
Breast Cancer
Recruiting
A Study of Skipping Radiation Therapy in People With Breast Cancer
HER2-positive Breast Cancer, Breast Cancer
Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amol Navathe, MD, PhD principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-visit patient text messaging, Default pended order and High risk bidirectional post-visit text messaging in people with Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Who Complete a Screening Mammogram Within 3 Months After the Visit (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.